ULTRA LYTE SODIUM REAGENT KIT— 510(k) K843453

Name: FDA 510(k) clearance K843453
Creator: U.S. Food and Drug Administration
Published: 1984-11-27

Substantially Equivalent

Ultra Quest Diagnostics, Inc.

FDA 510(k) clearance K843453 for ULTRA LYTE SODIUM REAGENT KIT, Substantially Equivalent on 1984-11-27. Applicant: Ultra Quest Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ultra Quest Diagnostics, Inc.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1984-09-05
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K843454 — ULTRA LYTE POTASSIUM REAGENT KIT1984-11-27
K842315 — ULTRA LYTE ANALYZER I 1001984-08-02

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.